N/A
N=25
Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty
Nasal Septum
Bottom Line
View on ClinicalTrials.gov: NCT00740480 ↗Enrolled (actual)
25
Serious AEs
—
Results posted
Aug 2009
Primary outcome: Primary: Coaptation (Tissue Approximation) — 23 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ENTrigue Surgical, Inc.
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Coaptation (Tissue Approximation) |
23 | — |
| SECONDARY Tissue Reaction to Implant |
18; 5; 0; 0; 2 | — |
Summary
The purpose of this research study is to learn more about the ENTact™ Septal Staple System device performance and to collect information to support its premarket application.
Eligibility Criteria
Inclusion Criteria
- Adult patients, between the ages of 18 and 65 years, with a clinically significant deviation of the nasal septum
- Patient is able to provide a signed informed consent form
- Patient will agree to comply with all study related procedures
- Patient is not pregnant at this time. If patient is of child-bearing age and capable of bearing children, a pre-operative pregnancy test confirmation is required to show that patient is not pregnant on the day of surgery
- Patient does not plan on becoming pregnant and is not breast feeding during the course of the study
Exclusion Criteria
- Patients who do not meet the inclusion criteria
- Patients who have had previous septoplasty
- Patients with uncontrolled diabetes
- Presence of infection at the site
- Smokers and severe drug and alcohol abusers
- Patients with autoimmune disease deemed clinically significant by Principal Investigator
Data sourced from ClinicalTrials.gov (NCT00740480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.